The Comparison of Two Crosslinked Hyaluronate for the Treatment of Osteoarthritis Pain

SciVision Biotech

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: HYAJOINT Plus; Device: Durolane

Study type: Interventional

Funder types: Industry

Identifiers

NCT04000204

RDCT-CKHP

Details and patient eligibility

About

The aim of this study is to compare the safety and effectiveness between two BDDE-crosslinked hyaluronate, HYAJOINT Plus and Durolane, for the Treatment of Knee Osteoarthritis Pain.

Enrollment: 142 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age from 35 to 85 years;
2. radiographic Kellgren-Lawrence grade II to III;
3. symptoms ≧6 months despite conservative treatments such as analgesics, NSAID and/or physical therapy;
4. average knee pain score ≧30mm on 100-mm visual analog scale (VAS) in recent one week;
5. radiographic evidence of bilateral knee OA not reason for exclusion if VAS pain in contralateral knee <30mm.

Exclusion criteria

1. previous orthopedic surgery in the lower extremity;
2. disabling osteoarthritis of hip or ankle;
3. previous IAHA within 6 months;
4. IA steroid or joint puncture within 3 months;
5. characters of severe acute synovitis under ultrasound (US) examination, such as Grade 3 in suprapatellar synovitis (SPS), suprapatellar effusion (SPE), medial compartment synovitis (MCS) or lateral compartment synovitis (LCS);
6. Any specific medical condition, such as rheumatoid arthritis, Lupus erythematous, hemiparesis, infection, neoplasm, and etc., that would interfere with assessments;
7. confirmed or suspected pregnancy or lactating;
8. known allergy history to any avian protein or HA product.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 2 patient groups

HYAJOINT Plus

Experimental group

Treatment:

Device: HYAJOINT Plus

Durolane

Active Comparator group

Treatment:

Device: Durolane